Senior Aseptic Processing Contamination Consultant

Job Title: Principal Aseptic Processing Contamination Consultant

Job Description

The Aseptic Processing Contamination Consultant provides full-time technical leadership to evaluate high-risk aseptic interventions and identify risk reduction opportunities across syringe, vial, and lyophilization operations. This role leads systematic reviews of aseptic processing activities to eliminate, replace, reduce, or control contamination risks, and supports corrective and preventive action (CAPA) and investigation activities. The consultant will serve as a key technical expert for contamination control strategy, regulatory remediation, and executive-level updates in a modern sterile pharmaceutical manufacturing environment.

Responsibilities

• Facilitate intervention assessment workshops five days per week to systematically evaluate high-risk aseptic interventions.
• Lead the evaluation of high-risk interventions using PDA I-REM methodology, contamination control strategy principles, Annex 1 expectations, and FDA aseptic processing guidance.
• Analyze contamination mechanisms associated with first-air disruption, aseptic connections, open-door interventions, glove contact, sterile product-contact surface exposure, and extended exposure duration.
• Support development of detailed process maps to document aseptic operations and intervention points.
• Perform contamination mechanism analyses and exposure chain assessments to understand and quantify contamination pathways.
• Conduct FMEA reviews to assess risk levels and prioritize mitigation actions for aseptic interventions.
• Develop and propose mitigation strategies that eliminate, replace, reduce, or control contamination risks in sterile manufacturing processes.
• Drive identification of opportunities to eliminate risk, replace high-risk activities with engineered controls, reduce risk exposure, and improve existing controls.
• Recommend contamination-control improvements such as closed systems, sterile connectors, pre-assembled manifolds, RABS enhancements, and automation opportunities.
• Provide technical support for executive updates, including preparation of executive summaries and clear communication of risk reduction strategies and progress.
• Support FDA remediation activities, including interpretation of FDA expectations for sterile manufacturing and alignment of site practices with regulatory guidance.
• Contribute to CAPA support documentation, including contamination mechanism assessments, risk reduction recommendations, and engineering opportunity assessments.
• Develop and maintain a prioritized implementation roadmap for contamination-control improvements and intervention-reduction initiatives.
• Apply first air principles and aseptic processing best practices to evaluate and redesign aseptic interventions.
• Collaborate with quality assurance, compliance, and manufacturing teams to ensure alignment with GMP, FDA guidance, and Annex 1 requirements.
• Support and interpret environmental monitoring programs, smoke studies, and media fill designs to confirm effectiveness of contamination-control strategies.
• Participate in process development and improvement efforts related to sterile drug product manufacturing and aseptic assembly operations.
• Contribute to audits and remediation efforts, including review of FDA 483 observations and development of sustainable corrective actions.
• Ensure that risk assessments and contamination-control strategies are clearly documented and traceable to CAPA and investigation records.

Essential Skills

• Minimum 15+ years of experience in sterile pharmaceutical manufacturing.
• Direct hands-on experience with aseptic filling operations.
• Practical experience with restricted access barrier systems (RABS), isolators, sterile filtration, lyophilization, and aseptic assembly operations.
• Proven experience leading contamination-control or intervention-reduction initiatives in sterile manufacturing environments.
• Deep technical understanding of first air principles and their application to aseptic interventions.
• Expertise in aseptic intervention design and assessment of human contamination pathways.
• Strong knowledge of Contamination Control Strategy (CCS) and its implementation in manufacturing operations.
• In-depth familiarity with Annex 1 requirements for sterile medicinal products.
• Comprehensive understanding of FDA sterile manufacturing expectations and aseptic processing guidance.
• Experience working with PDA Technical Reports and PDA I-REM methodology for risk evaluation.
• Ability to design, interpret, and optimize environmental monitoring programs in aseptic areas.
• Skill in interpreting smoke studies to assess airflow, first air protection, and intervention impact.
• Experience in media fill design and justification to demonstrate aseptic process robustness.
• Proficiency in developing process maps and performing risk assessments related to aseptic interventions.
• Strong Experience in GMP, quality assurance, compliance, and remediation activities, including response to FDA 483 observations.
• Ability to support CAPA activities related to aseptic processing and contamination control.

Additional Skills & Qualifications

• Experience in process development and process improvement for sterile drug product manufacturing.
• experience in audit support and remediation activities within regulated pharmaceutical environments.
• Familiarity with contamination control strategies involving RABS enhancements and engineered controls.
• Experience with FDA remediation projects and alignment of site practices with regulatory expectations.
• Ability to prepare clear executive summaries and technical documentation for leadership and regulatory stakeholders.
• Comfort working with CAPA and investigation identifiers such as CAPA-102537, CAPA-102539, and ICP-100445 as part of structured remediation programs.
• Strong analytical and problem-solving skills with a focus on risk reduction and continuous improvement.
• Effective communication skills to lead workshops, explain complex contamination mechanisms, and influence cross-functional teams.

Work Environment

This role operates primarily in a sterile pharmaceutical manufacturing environment, including aseptic processing areas where syringes, vials, and lyophilized products are filled and assembled. The consultant will work closely with operations, quality, and engineering teams in production and support areas, with frequent presence in manufacturing zones utilizing technologies such as RABS, isolators, sterile filtration systems, lyophilization equipment, and automated aseptic assembly lines. The standard schedule is Monday through Friday, 9:00 a.m. to 5:30 p.m., with full-time on-site engagement to facilitate workshops and support remediation activities. The facility is a newer manufacturing site focused on driving change and implementing modern contamination-control strategies, providing opportunities to influence processes, equipment selection, and overall aseptic design.

This is a Contract position based out of Baltimore, MD.

The pay range for this position is $75.00 - $125.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Baltimore,MD.

This position is anticipated to close on Sep 29, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

If you would like to request a reasonable accommodation, such as the modification oradjustment of the job application process or interviewing process due to a disability,please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.